Kornimate/medical-research-clean huggingface dataset:
venous vascular closure system versus manual compression following single shot device af ablation

Conditions: Atrial Fibrillation

Summary: prospective, randomized, controlled, multi-center study to compare the safety and efficacy of the perclose prostyle suture-mediated closure device (pps) as to manual compression (mc) for venous hemostasis following single shot device (ssd) based pulmonary vein isolation (pvi).

the aim of this study is to show that the time to ambulation after pvi can be reduced by deploying vascular closure device versus manual compression and a figure-of-8 suture only. safety, efficacy and feasibility of the pps device should be proven, too.

Eligibility criteria:
inclusion criteria: * patients age \>18 * elective catheter ablation for atrial fibrillation using a 6 to 14 fr inner diameter introducer sheath with a minimum of 1 and maximum of 2 femoral venous access sites exclusion criteria: * active systemic or cutaneous infection, or inflammation in vicinity of the groin * platelet count \< 100,000 cells/mm3 * bmi \> 45 kg/m2 or \< 20 kg/m2 * attempted femoral arterial access or inadvertent arterial puncture * procedural complications that interfered with routine recovery, ambulation, or discharge times * incorrect sheath placement * intraprocedural bleeding or thrombotic complications * access site-specific eligibility criteria to exclude problems with gaining access or location of sheath
assessing the maternal outcome monitoring systems

Conditions: Maternal Death; Maternal Complication of Pregnancy

Summary: pregnancy-related death is a growing public health issues, which are of particular concern to minority groups, including african-americans and spanish-speaking latinas. our proposal aims to improve a patient's ability to detect warning signs of pregnancy related death and seek medical care.

pregnancy-related death (prd) rates have risen 120-200% in the united states in the past two decades, and experts estimate that 40-60% of these cases are preventable. improvement initiatives are predominantly hospital-based and rely on perinatal people recognizing their own symptoms and seeking care without ample support or education. we hypothesize that we can improve patients' self-efficacy and decision-making about when to seek care by helping them to self-monitor symptoms and by providing decision support. we propose to develop a mhealth-based, patient-reported outcome (pro) and decision-support system to help mothers determine when to seek care for warning signs of prd. our project focuses on diverse populations facing postpartum disparities, particularly african- american and spanish-speaking latina women. this protocol involves a single-arm pilot trial assessing the feasibility and preliminary effectiveness of moms/mama for improving knowledge and patient activation among postpartum patients.

Eligibility criteria:
inclusion criteria: * greater than 28 weeks pregnant * receiving healthcare in the united states * age 18 years or older * \[identify as black or african american race and able to speak and read english, and preferred language of english\] or \[identify as hispanic/latino ethnicity and spanish able to speak and read spanish and preferred language of spanish\] * planned delivery at the following newyork-presbyterian hospitals: children's hospital of new york, allen hospital, weill cornell medical center, lower manhattan hospital exclusion criteria: * severe cognitive impairment * major psychiatric illness * concomitant terminal illness that would preclude participation.

Keywords: pregnancy related death patient reported outcomes mhealth patient activation
in dexmedetomidine for procedural sedation in pediatric closed reductions for distal forearm fractures

Conditions: Conscious Sedation; Distal Radius Fracture

Summary: the primary objective of this study is to evaluate the sedative, and analgesic effects of intranasal (in) dexmedetomidine (dex) in children presenting to a pediatric emergency department (ped) who undergo conscious sedation for reduction of closed distal forearm fractures when compared to those receiving intravenous (iv) ketamine. the secondary objective is to compare each sedation technique for safety and procedural outcomes.

distal forearm fractures are often are displaced requiring conscious sedation for closed reduction in the emergency department. our institution's current standard of care consists of in fentanyl for baseline control of pain, and for those fractures requiring reduction; typically iv ketamine is utilized. ketamine is typically well tolerated but is not without concerns including hypertension, vomiting, and the rare but serious complication of laryngospasm. dexmedetomidine (dex) offers a possible alternative to iv ketamine. dex has been used safely in the critical care setting for both pediatrics and adults. it has been well documented as being quite effective in sedation, amnesia and analgesia. using in dex for ped procedural sedation has the potential to obviate the need for iv placement and may offer a better conscious sedation profile than ketamine with respect to sedation, analgesia, and adverse outcomes. our overall project would be to assess the efficiency of in dex in comparison to iv ketamine, for proper sedation and analgesic coverage for children undergoing closed reduction of distal forearm fractures.

Eligibility criteria:
inclusion criteria:verbal children aged 2-18 with a single extremity displaced forearm fracture requiring conscious sedation and reduction will be screened for enrollment. exclusion criteria: 1. under age 2 years old or patients \> 18 years old 2. multiple fractures 3. significant multisystem trauma 4. glasgow coma scale (gcs \< 15) 5. complex fractures that aren't deemed reducible in ed 6. reported allergy to alpha -2-agonists 7. pregnancy 8. intoxication 9. baseline hypotension as \ 11 years of age 10. patients with prior reductions attempted at outside facilities 11. aberrant nasal anatomy that precludes in medications 12. chronic health issues that can affect dex metabolism 13. history of adverse reactions to anesthesia 14. patients transferred from outside facilities 15. open fractures

Keywords: intranasal dexmedetomidine
contrast nephropathy associated ffa

Conditions: Contrast-induced Nephropathy; Acute Kidney Injury

Summary: after the use of iodinated contrast agents, there is a risk of developing contrast nephropathy. limited data in the literature are available on the incidence of contrast nephropathy after fluorescein angiography (ffa), which is an iodine-free organic contrast. additionally, factors associated with contrast nephropathy after ffa are not clearly understood. our study aims to evaluate these points.

it is known that patients are at risk of developing contrast nephropathy after ffa with iodinated contrast media. however, although it is known that contrast nephropathy may develop after ffa with fluorescein, a non-iodinated organic contrast agent, there is very limited data in the literature. in this study, we aimed to determine the incidence of contrast nephropathy after ffa for retinopathy evaluation and to evaluate the associated factors (age, gender, diabetes mellitus, hypertension, chronic kidney disease, baseline renal function, medications, etc.). our study was planned prospectively. patients over the age of 18 years who applied to prof. dr. cemil taşcıoğlu city hospital eye clinic as outpatients and who did not meet the exclusion criteria and agreed to participate in the study will be included in our study. age, gender, demographic, clinical and laboratory data of these patients will be recorded from the patient file and hospital data processing system. the definition of contrast nephropathy is defined as an increase in serum creatinine (scr) ≥0.5 mg/dl or more than 25% of the baseline value in the study titled "contrast-induced kidney injury:focus on modifiable risk factorsand prophylactic strategies", "risk of nephropathy after intravenous administration of contrast material: a critical literature analysis. in this study, an increase of 0.3 mg/dl in serum creatinine within 48 hours after contrast was accepted. the definition of contrast nephropathy will be evaluated separately as both an increase of 0.5 mg/dl or 25% increase in creatinine value compared to baseline and an increase of 0.3 mg/dl compared to baseline. in this way, there are studies in which the frequency of contrast nephropathy was evaluated separately according to both criteria in the same study.

Eligibility criteria:
inclusion criteria: * over 18 years old. patients with an indication for ffa. those who agreed to participate in the study. exclusion criteria: * patients with nephrotoxic drug exposure in the last two weeks * patients who underwent imaging management requiring the use of other contrast agents in the last month (such as coronary angiography, ct angiography) * patients with unstable hemodynamics * patients with obstructive uropathy * patients with end-stage renal failure with egfr\<15 * patients on a routine hemodialysis program
statin therapy vs. therapeutic lifestyle changes and supplements

Conditions: Hyperlipidemia

Summary: randomized trial in a primary prevention population * all participants have high ldl cholesterol group one will take simvastatin 40 mg/day group two will make therapeutic lifestyle changes,and take supplements consisting of red yeast rice and fish oil

this is a randomized primary prevention trial to compare the ldl lowering effects of an alternative regimen to statins(simvastatin) this alternative regimen is over the counter and available at health food stores. the alternative regimen consists of lifestyle changes including a mediterranean diet,exercise program, and stress reduction, with red yeast rice 1200 mg twice per day and fish oil 6 grams/day. the second group, run at the same time will take zocor(simvastatin) 40 mg per day with standard counseling

Eligibility criteria:
inclusion criteria: * adults ages 18-75 yrs, who meet atp iii criteria to be treated for high cholesterol. all participants must be able to exercise and be willing to be randomized to either arm of the study exclusion criteria: * no history of bypass surgery, stents, or hx of myocardial infarction. cannot have uncontrolled hypertension(sbp\>190 or dbp\>100), cannot have known intolerance to one of the study drug

Keywords: red yeast rice pharmaceutical grade fish oil simvastatin primary prevention
natural ovarian stimulation

Conditions: Infertility

Summary: to overcome unsuitable effects of controlled ovarian hyperstimulation (coh )while maintaining large oocyte availability, investigators elaborated an innovative protocol (natural ovarian stimulation) that dissociates e2 production from multiple follicle development. the purpose of this prospective, randomized trial is to demonstrate that, in a good prognosis ivf-et population, the physiological e2 environment resulting from natos significantly improves ivf-et outcome when compared to the conventional gnrh antagonist protocol.

controlled ovarian hyperstimulation (coh) seeks to improve ivf-et results by increasing per-cycle oocyte and embryo availability. yet, the coexistence of multiple preovulatory follicles engenders compulsory alterations in the endocrine milieu of the follicular phase. the most evident of them are the extremely high serum estradiol (e2) levels. the 10 to 15-fold increase in e2 levels as a result of coh has been shown to provoke unwanted consequences in both embryo quality and uterine receptivity. therefore, investigators elaborated an innovative coh protocol (natural ovarian stimulation) that aimed at dissociating e2 production from multiple follicle development. to obtain this effect, they virtually curtailed endogenous lh production by using gnrh antagonist doses as strong and frequent enough to maintain e2 levels around the physiological range during standard exogenous fsh-only administration. given that high e2 levels are commonly reached in patients having a normal follicle endowment, natos should target this group of good prognosis ivf-et candidates. indeed, this new coh approach was first tested in a pilot study that included 15 good prognosis ivf-et candidates, aged 25-35 years, who volunteered to undergo natos. 11 out of 15 patients achieved a pregnancy. these pilot results spurred them to conduct a prospective, randomized trial to demonstrate that, in a good prognosis ivf-et population, the physiological e2 environment resulting from natos significantly improves ivf-et outcome when compared to the conventional gnrh antagonist protocol.

Eligibility criteria:
inclusion criteria: * ivf-et candidates (excluding pgd and oocyte donor); * body mass index from 18 to 30 kg/m2; * non smokers; * regular menstrual cycles (25-35 days); * presence of both ovaries; * antral follicle count (follicles measuring from 3 to 10 mm in diameter) ranging from 10 to 30 on cycle days 2 to 4; * serum amh levels ranging from 0.5 to 5.0 ng/ml; * normal endometrium at ultrasound (us) and/or hysteroscopy; * informed consent signed exclusion criteria: * iatrogenic ovarian insufficiency (surgery, radiotherapy, chemotherapy); * uterine abnormalities as demonstrated by pelvic us and/or hysteroscopy; * usual contra-indications for coh (cancer risk, blood coagulation disorders, etc) * renal insufficiency

Keywords: controlled ovarian hyperstimulation estradiol embryo implantation endometrial receptivity fertility preservation
activating transversus abdominis muscle

Conditions: Low Back Pain; Rehabilitative Ultrasound; Spinal Stabilization

Summary: transversus abdominis (tra) is an important muscle for spinal stabilization. abdominal draw-in maneuver (adim) is a method that selectively activates tra without activating external oblique (eo) and internal oblique (io) muscles. individuals with low back pain may have some troubles to understand proper contraction of tra. therefore, to contract the tra, two different feedback techniques have been used to instruct. in this observational study we aim to investigate the effects of two different biofeedback methods to teach patients the proper activation of tra muscle using adim. we aim to find out the differences between visual and traditional tactile biofeedback and decide which one is practical and easy to teach the patients in clinical environment.


Eligibility criteria:
inclusion criteria: * healthy volunteers between ages of 18-25 exclusion criteria: * volunteers excluded if they had (1) history of lbp, (2) spinal or abdominal surgeries, (3) neuromusculer or romatologic diseases. each volunteer gave their informed consent.
safety and efficacy study of bee venom to treat knee osteoarthritis

Conditions: Persons With Mild to Moderate Knee Osteoarthritis

Summary: study wishes to determine if the use of injectable bee venom is a safe and effective treatment for persons with mild to moderate knee osteoarthritis and would result in decreased report of pain and discomfort, increased function during daily activities, decrease use of analgesic meds, and improvement in walking and climbing steps. we will be using histamine as a control. 40 subjects will be enrolled in a 3:1 allocation ratio between bee venom and histamine. each injection of bee venom dosage will consist of 100 micrograms of dried bee venom in 0.1 ml. of 0.5% preservative free xylocaine. the histamine dosage will consist of .0025 milligrams of histamine in 0.5% preservative free xylocaine. subjects will visit the study center for 14 visits over an 18 week span. the clinical hypothesis is that bee venom is an effective treatment for osteoarthritis and will reduce pain and discomfort, increase range of motion, increase daily function, decrease walking and stair climbing time, and decrease the need of analgesic medication for a period of time beyond treatment (after the study has concluded.) the clinical safety hypothesis is that for persons not allergic to bee venom (patients allergic will not be allowed to enter into the study) the side effects will be small. the most common side effects for bee venom and histamine will be redness and itchiness which will be tolerable and safe.


Eligibility criteria:
inclusion criteria: * meet clinical criteria for osteoarthritis in one knee * morning stiffness less than 30 minutes duration * vas pain level of 4 to 8 on a 0 to 10 scale when walking * older than 35 years of age * on a stable dose of medication or none at all due to intolerance * ability to tolerate acetaminophen as their only pain medication for the entire study * ability to read, understand, and give informed consent and sign the informed consent form exclusion criteria: * allergy to bee venom or histamine * allergy to lidocaine * any type of inflammatory arthritis such as ra, sle, psoriatic * fibromyalgia or any pain problem that requires the use of pain medication or anti-inflammatory * depression or any condition that interferes with memory or critical analysis * history of prolotherapy, bee venom therapy, or injection of hyaluronic acid or cortisone within the last 3 months * osteoarthritis of the hip, ankle, or any condition that interferes with walking 50 ft. or up and down stairs * elevated crp, sed rate * recent injury to the knee which is causing pain or functional problems * any previous invasive procedure on the study knee * inability to understand the informed consent form or refusal to sign it * cardiac disease interfering with ability to get epinephrine * vas pain level greater than 8 on a 0 to 10 scale when walking * inability to stop anti-inflammatory medication for the entire study and use only acetaminophen * taking beta blockers * taking chronic anti-histamines
delphinus softvue™ roc reader study

Conditions: Breast Cancer; Breast Neoplasms

Summary: the purpose of this multi-reader, multi-case (mrmc) reader study is to evaluate reader performance when softvue™ automated breast ultrasound and screening mammography are combined, compared to screening mammography alone, in women with dense breast parenchyma. this includes obtaining information that can be used to properly plan, design, and power future roc reader studies. this reader study will include a minimum of 6 radiologist readers and an enriched sample of at least 100 breast screening or diagnostic cases to be selected from the library of images collected under delphinus protocol #dmt-2015.001 (nct03257839). the reader study image case set will be enriched with cancer cases.


Eligibility criteria:
radiologists of any age, sex, race, ethnicity, or institutional affiliation may participate as study readers. all readers must meet the following inclusion criteria: * hold a current united states medical license * be american board of radiology certified * be mqsa-qualified * be experienced in reading ffdm images on a monitor (softcopy) * be experienced in reading breast ultrasound images on a monitor (softcopy) * have completed a financial disclosure showing no conflicts of interest * have provided a current curriculum vitae (cv) * have provided a signed readers' agreement * have provided written informed consent all qualified and confirmed readers will complete a multi-module softvue™ training program prior to their participation in a reading session for this study.

Keywords: breast screening breast imaging softvue mammography ultrasound reader study roc auc breast cancer detection dense breasts breast density dense breast tissue dense breast parenchyma
the effect of parental participation on newborn comfort during diaper care

Conditions: Preterm

Summary: it was aimed to determine the effect of parental participation on newborn comfort during diaper care practice in preterm infants. h1: parental participation during infant diaper care practice in preterm infants has an effect on newborn comfort. h2: there is a difference in the effect of parent diaper care practice and the participation of the mother or father on newborn comfort in preterm infants. h3: there is a difference between the stress levels of parents before the application of infant diaper care in preterm infants.

the expectation of all parents is to have a healthy baby at the end of the pregnancy. however, newborns being born unexpectedly early and being admitted to the neonatal intensive care unit is a stressful situation for both newborns and parents. during this process, parents of preterm infants experience anxiety, loss of control, fear of the future, depression, role change and concerns about the improvement of the baby's condition. it is important for parents to actively participate in care within the framework of family-centered care practices in order to reduce the newborn's stress level, increase its comfort and improve its environment and to increase the families' ability to cope with this situation.infant care, which is repeated many times a day in the neonatal intensive care unit, is one of the care practices that include tactile stimuli. studies have observed that preterm infants' stress increases during diaper changes. for this reason, it is important to plan the necessary invasive practices to increase comfort during diaper changes, to include parental participation in these procedures, and to determine the effect of these interventions on the infants' comfort and to include them in the literature.

Eligibility criteria:
inclusion criteria: * infants whose gestational age is between ≥34 weeks and ≤36+6 weeks at the time of application * infants with stable health conditions exclusion criteria: * intubated * those with very low and extremely low birth weight at the time of procedure * having a chronic disease * those with congenital anomalies * having undergone a surgical procedure * having neurological symptoms * receiving oxygen support * diagnosed with sepsis * sedated * a pharmacological analgesic method was used four hours before. * parents who do not want to participate in care

Keywords: diaper care newborn comfort parental participation preterm